Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02557412 |
| Other study ID # |
PINML01 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Hospital Universitario La Paz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with
conventional treatment, improves the lipid profile of patients with dyslipidemia and
mild-moderate apnea-hypopnea syndrome (OSA).
Secondary objectives:
- Determine the additional effect of CPAP on insulin resistance and dyslipidemia in
patients with mild-moderate OSA.
- Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with
dyslipidemia and mild-moderate OSA.
DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional
treatment.
STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and
in stable treatment during the last month with diet, cholesterol lowering drug, and
cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.
Sample size. 38 patients who completed the test in each treatment arm.
TREATMENT
Patients will be randomized to one of the following treatment arms form:
1. hygiene and dietary recommendations.
2. lifestyle intervention (more strict and promotion of daily physical activity and dietary
control).
3. Treatment with positive airway pressure (CPAP).
ENDPOINTS:
Efficacy endpoints.
- Primary endpoint: LDL-cholesterol.
- Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high
sensitivity (hsCRP).
- Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α),
oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion
molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic
activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A /
hypocretin-1 and ghrelin).
- Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model
Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI),
thyroid-stimulating hormone (TSH).
- Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep
Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ).
Security endpoints.
- Notification of clinical adverse events.
- Compliance with CPAP (average hours use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
Description:
OBJECTIVES
Main objective: To assess if six months of treatment with CPAP, associated with conventional
treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate
apnea-hypopnea syndrome (OSA).
Secondary objectives:
- Determine the additional effect of CPAP on insulin resistance and dyslipidemia in
patients with mild-moderate OSA.
- Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with
dyslipidemia and mild-moderate OSA.
- Analyze the impact of supplemental CPAP treatment on glycemic control and the
concentration of hsCRP in patients with dyslipidemia and mild-moderate OSA.
- Establish the impact of supplemental CPAP treatment on quality of life related to health
of patients with dyslipidemia and mild-moderate OSA.
- Evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers,
sympathetic tone and regulating hormones intake in patients with dyslipidemia and
mild-moderate OSA.
- Correlate CPAP induced changes in lipid levels with the changes produced in the basal
inflammatory response, oxidative stress, sympathetic activity and intake regulating
hormones.
- Compare the effect of CPAP with promotion of daily physical activity on lipid profile in
patients with dyslipidemia and mild-moderate OSA.
- Identify the subgroup of patients with uncontrolled dyslipidemia and mild-moderate OSA
in wich six months of treatment with CPAP achieve a more pronounced reduction in blood
lipids.
DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional
treatment.
STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and
in stable treatment during the last month with diet, cholesterol lowering drug, and
cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics.
Sample size. 38 patients who completed the test in each treatment arm.
TREATMENT
Patients will be randomized to one of the following treatment arms form:
1. hygiene and dietary recommendations.
2. lifestyle intervention (more strict and promotion of daily physical activity and dietary
control).
3. Treatment with positive airway pressure (CPAP).
ENDPOINTS Efficacy endpoints.
- Primary endpoint: LDL-cholesterol.
- Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high
sensitivity (hsCRP).
- Systemic Biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress
(8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic
activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A /
hypocretin-1 and ghrelin).
- Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and HOMA and QUICKI
indexes, TSH.
- Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ.
Security endpoints.
- Notification of clinical adverse events.
- Compliance with CPAP (average hours use per day).
- Epworth Sleepiness Questionnaire.
- Development of cardiovascular events.
STATISTICAL PROCEDURES Data will be expressed as mean ± standard deviation, median
(interquartile range) or percent, depending on type and distribution. For comparison between
groups, or t-Student test, or the Mann-Whitney U-test or chi-square test will be used, as
appropriate. The relationships between variables will be analyzed by Pearson correlation and
multiple linear regression.
The treatment effect will be evaluated by analysis of variance for repeated measures with
post-hoc multiple comparisons, using the Bonferroni test. A model of multiple logistic
regression will be applied to determine the variables associated with treatment response. P
values will be considered statistically significant <0.05.
